Declaration of Conformity Manufacturer: Authorised Representative: Compliance is applicable from the date listed below. All supporting documentation is retained at the premises of the manufacturer. This declaration is issued under the sole responsibility of Signed at Sydney, Australia on: __________________________________________ Product: Intended Use: First issued: Classification: GMDN: Conformity Assessment Route: 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia ResMed SAS Parc Technologique de Lyon 292 Allée Jacques Monod 69791 Saint Priest Cedex France TÜV SÜD Product Service GmbH Ridlerstraße 65 80339 München Germany S9 Autoset The S9 AutoSet self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S9 AutoSet self-adjusting system is intended for home and hospital use. IIa according to Rule 9 60711 Home CPAP unit Annex II (excluding Section 4), 93/42/EEC G1 049861 0158 11 December 2019 Johanna Wright Director of Regulatory Affairs ResMed Pty. Ltd. EC109 30 October 2009 0123 Notified Body: EC Certificate Number: We herewith declare that the above mentioned products are in conformity with the Council Directive 93/42/EEC for medical devices including the MDD amendment 2007/47/EC, Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. ResMed Pty. Ltd. ResMed Pty. Ltd.
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Declaration of Conformity
Manufacturer: Authorised Representative:
Compliance is applicable from the date listed below. All supporting documentation is retained at the premises of the manufacturer.This declaration is issued under the sole responsibility of
Signed at Sydney, Australia on:
__________________________________________
Product:
Intended Use:
First issued:
Classification:
GMDN:
Conformity Assessment Route:
1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
ResMed SAS Parc Technologique de Lyon 292 Allée Jacques Monod 69791 Saint Priest Cedex France
TÜV SÜD Product Service GmbH Ridlerstraße 65 80339 München Germany
S9 Autoset
The S9 AutoSet self-adjusting system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). The S9 AutoSet self-adjusting system is intended for home and hospital use.
IIa according to Rule 9
60711 Home CPAP unit
Annex II (excluding Section 4), 93/42/EEC
G1 049861 0158
11 December 2019
Johanna Wright Director of Regulatory Affairs ResMed Pty. Ltd.
EC10930 October 2009
0123
Notified Body:
EC Certificate Number:
We herewith declare that the above mentioned products are in conformity with the Council Directive 93/42/EEC for medical devices including the MDD amendment 2007/47/EC, Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment.
ResMed Pty. Ltd.
ResMed Pty. Ltd.
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